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BIO recently published the July 2012 version of its quarterly therapeutic newsletters. These six newsletters focus on the therapeutic areas of member companies and include updates from biotech stakeholders around Washington, including Congress, FDA, NIH, and patient organizations.

The therapeutic areas covered by these newsletters are:

Cardiology, Pulmonology, & Blood

Nephrology, Endocrinology, Metabolism, & Gastroenterology

Oncology

Allergy, Infectious Disease, & Antiviral

Rheumatology, Inflammation, Anesthesia, & Pain

Neurology & CNS

The below is an excerpt from the “Focus on Nephrology, Endocrinology, Metabolism, & Gastroenterology” newsletter. To download it in its entirety, please click here. If you have any questions or would like to receive a specific set of therapeutic newsletters, please contact Charles Crain at ccrain@bio.org.

On August 28, 2012, the FDA Gastrointestinal Drugs Advisory Committee will meet to discuss the results from clinical trials of supplemental biologics license application (sBLA) 125057/232, for Humira (adalimumab), by Abbott Laboratories, for the proposed indication for reducing signs and symptoms, and achieving clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

FDA intends to make background material available to the public no later than 2 business days before the meeting. For more information on this meeting, or to find the materials once they are posted, please click here.

NIDDK Scientists: Two Drugs Better Than One to Treat Youth With Type 2 Diabetes

A combination of two diabetes drugs, metformin and rosiglitazone, was more effective in treating youth with recent-onset type 2 diabetes than metformin alone, a study funded by NIDDK has found. Adding an intensive lifestyle intervention to metformin provided no more benefit than metformin therapy alone.

The study also found that metformin therapy alone was not an effective treatment for many of these youth. In fact, metformin had a much higher failure rate in study participants than has been reported in studies of adults treated with metformin alone.

The Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study is the first major comparative effectiveness trial for the treatment of type 2 diabetes in young people. TODAY was funded by NIDDK.

“The results of this study tell us it might be good to start with a more aggressive drug treatment approach in youth with type 2 diabetes,” said Philip Zeitler, M.D., Ph.D., the TODAY study chair and a pediatric endocrinologist at Children's Hospital Colorado, Aurora. “We are learning that type 2 diabetes is a more aggressive disease in youth than in adults and progresses more rapidly, which could be why metformin alone had a higher than expected failure rate.”

BIO would like to invite you to participate in our upcoming educational webinar series in September and October on key provisions contained in the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Jumpstart Our Business Startups (JOBS) Act.

The FDASIA webinars, scheduled for September 13 and September 26, will provide information on the intent and goals of the provisions in FDASIA, including Enhanced Communications, NME Reviews, Expanded Accelerated Approval, and Breakthrough Therapies. Industry experts will also discuss implementation issues and timelines.

The JOBS Act webinars, scheduled for September 18 and October 3, will offer companies information on the key facets of the law and offer expert analysis on how to navigate the new rules. The JOBS Act contains exciting new fundraising methods for biotech companies, including the IPO On-Ramp, Crowdfunding, and changes to SEC Regulations A and D.

The webinars are free for all BIO R&D members and BIO state affiliates. Non-member R&D companies are invited to join for $100. For more information or to register for the webinars, please email Charles Crain at ccrain@bio.org.

NCATS Announces Institutional CTSA Program

The NCATS CTSA program supports disease- and condition-specific networks funded by other NIH Institutes and Centers. NCATS has announced that its CTSA program will include Institutional CTSA Awards. Institutional CTSAs are made to degree granting institutions or groups of institutions that receive significant funding from the NIH. CTSAs require institutional commitment, the status of a major scientific and administrative entity within and across an applicant and partner institution(s), and a CTSA PD(s)/PI(s) with the authority and influence necessary to successfully create an institutional home for clinical and translational research.

To learn more about the NCATS Institutional CTSA Program (RFA-TR-12-006), please click here. The letter of intent is due December 10, 2012 and the application is due January 8, 2013.